DRL To Initiate Voluntary Action At Duvvada Unit

Hyderabad: City-based pharma behemoth Dr Reddy’s Laboratories on Sunday informed the bourses that the United States Food and Drug Administration (USFDA) has asked the company to initiate voluntary action at its Duvvada formulations facility.

“With regard to the audit of our formulations manufacturing plant (Vizag SEZ Plant 1 – FTO 7) at Duvvada, Visakhapatnam, we would like to inform you that we have been notified by the US FDA, that the inspection classification of the above-referred facility is determined as Voluntary Action Initiated (VAI),” the company informed the bourses on Sunday.

A VAI inspection classification indicates that, although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.

In August 2019, Dr Reddy’s Laboratories had said that US FDA had issued a Form 483 with eight observations after completion of inspection at this unit.-Times Of India